Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas

This study compared in vitro dissolution characteristics and other quality measures of different amoxicillin, metronidazole, and zidovudine products purchased in the Americas to a comparator pharmaceutical product (CPP). These three drugs are classified as Biopharmaceutics Classification System Class I drugs with the possibility that dissolution findings might be used to document bioequivalence. All investigated zidovudine products were found to be in vitro equivalent to the CPP. Only 3 of 12 tested amoxicillin products were found to be in vitro equivalent to the CPP. None of the tested metronidazole products were in vitro equivalent to the CPP. These findings suggest but do not confirm bioinequivalence where in vitro comparisons failed, given that an in vivo blood level study might have confirmed bioequivalence. At times, identifying a CPP in one of the selected markets proved difficult. The study demonstrates that products sold across national markets may not be bioequivalent. When coupled with the challenge of identifying a CPP in different countries, the results of this study suggest the value of an international CPP as well as increased use of BCS approaches as means of either documenting bioequivalence or signaling the need for further in vivo studies. Because of increased movement of medicines across national borders, practitioners and patients would benefit from these approaches.

Institutional arrangements in the emerging biodiesel industry: Case studies from Minas Gerais-Brazil

Connecting (small) family farmers to the emerging biodiesel industry requires careful design of the institutional arrangements between the producers of oil crops and the processing companies. According to institutional economics theory, the design of effective and efficient arrangements depends on production and transaction characteristics, the institutional environment, and the organizational environment supporting the transaction between producers and the industry. This paper presents a comparative study on two cases in the feedstock-for-biodiesel industry in the state of Minas Gerais, Brazil. The two case studies represent the production and transaction system of soybeans (Glycine max L Merrill) and castor beans (Ricinus communis L). Important elements of effective and efficient institutional arrangements are farmer collective action, availability of technical and financial support, and farmer experience with particular crops. (C) 2011 Elsevier Ltd. All rights reserved.

Stethoscopes with hearing aid use: case studies

Introduction: Description for using stethoscopes adapted to hearing aids. Aim: To describe the adaptation of HAs to stethoscopes used by 2 students in the health field with bilateral hearing impairment. Case reports: Two subjects with hearing loss had their stethoscopes coupled to HAs because of the individual requirements of their professions (healthcare) to perform auscultation. Conclusion: The improvement was measured in situ, and satisfaction was evaluated using a subjective questionnaire. The use of a stethoscope coupled to an HA allowed students with hearing loss to perform auscultation.